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Let's Play! Healthy Kids After Cancer

Primary Purpose

Childhood Acute Lymphoblastic Leukemia in Remission, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone Coaching Program
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Acute Lymphoblastic Leukemia in Remission

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 4.0 years and < 11.0 years of age at the time of recruitment
  • Previously diagnosed of ALL and currently in remission
  • Between 1-5 years post completion of chemotherapy
  • BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)

Exclusion Criteria:

  • History of cranial radiation therapy
  • History of bone marrow transplant
  • History of relapse of ALL
  • Diagnosis of Down's Syndrome
  • Comorbidities of obesity that require immediate subspecialist referral
  • Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity
  • Significant psychiatric or neurologic disorders that would impair compliance with study protocol
  • Current participation in a weight-loss program

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota
  • Masonic Cancer Center, University of Minnesota
  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Phone Coaching Program

Standard Care Control

Arm Description

Participants will receive a nutrition and physical activity phone coaching program, in addition to standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.

Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.

Outcomes

Primary Outcome Measures

Feasibility: Number of participants who complete 8 of 10 intervention sessions
Measured by intervention session completion rates.
Retention: Number of participants who complete 6-month outcome assessments
Measured by completion of the 6-month outcome assessment.
Acceptability: Number of participants who report high satisfaction with the intervention
Measured by parent survey of satisfaction with intervention materials and sessions.

Secondary Outcome Measures

Change in children's physical activity
Measured by ActiGraph accelerometers
Change in children's dietary intake
Measured by Nutrition Data System for Research (NDSR) interview
Change in children's BMI
Staff-measured height and weight
Change in children's biomarker outcome measures
Measured by serum blood samples
Change in children's energy level
Measured by questionnaire: PedsQL Multidimensional Fatigue Scale

Full Information

First Posted
January 23, 2015
Last Updated
June 7, 2019
Sponsor
HealthPartners Institute
Collaborators
National Cancer Institute (NCI), Masonic Cancer Center, University of Minnesota, Children's Hospitals and Clinics of Minnesota, St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02361047
Brief Title
Let's Play! Healthy Kids After Cancer
Official Title
Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Cancer Institute (NCI), Masonic Cancer Center, University of Minnesota, Children's Hospitals and Clinics of Minnesota, St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.
Detailed Description
Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of all childhood malignancies. Treatment of childhood ALL has a high success rate, with long-term event-free survival of >85%. Treatment success, however, has not come without cost. Recognition of long-term health problems related to childhood cancer therapies is growing. Both during and after therapy, children treated for ALL are at risk for fatigue, reduced physical activity, poor dietary intake, and excessive weight gain, which are driven by physiological (chemotherapy-induced) changes and social (home/environmental) factors. The goals of this pilot study are to evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to prevent unhealthy weight gain among 60 childhood ALL survivors, 4-10 years of age. Participants will be randomly assigned to either the phone-delivered parent-targeted nutrition and physical activity intervention or a standard-of-care control group. Intervention success will be benchmarked by changes in key weight-related behaviors (physical activity and dietary intake) over the 6-month trial, and initial impact of the intervention on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be examined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Acute Lymphoblastic Leukemia in Remission, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone Coaching Program
Arm Type
Experimental
Arm Description
Participants will receive a nutrition and physical activity phone coaching program, in addition to standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
Arm Title
Standard Care Control
Arm Type
No Intervention
Arm Description
Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
Intervention Type
Behavioral
Intervention Name(s)
Phone Coaching Program
Intervention Description
Participants in this group will receive a 10-session nutrition and physical activity program delivered via phone by a health behavior coach to promote healthy lifestyle changes. Participants will also receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
Primary Outcome Measure Information:
Title
Feasibility: Number of participants who complete 8 of 10 intervention sessions
Description
Measured by intervention session completion rates.
Time Frame
6 months
Title
Retention: Number of participants who complete 6-month outcome assessments
Description
Measured by completion of the 6-month outcome assessment.
Time Frame
6 months
Title
Acceptability: Number of participants who report high satisfaction with the intervention
Description
Measured by parent survey of satisfaction with intervention materials and sessions.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in children's physical activity
Description
Measured by ActiGraph accelerometers
Time Frame
6 months
Title
Change in children's dietary intake
Description
Measured by Nutrition Data System for Research (NDSR) interview
Time Frame
6 months
Title
Change in children's BMI
Description
Staff-measured height and weight
Time Frame
6 months
Title
Change in children's biomarker outcome measures
Description
Measured by serum blood samples
Time Frame
6 months
Title
Change in children's energy level
Description
Measured by questionnaire: PedsQL Multidimensional Fatigue Scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 4.0 years and < 11.0 years of age at the time of recruitment Previously diagnosed of ALL and currently in remission Between 1-5 years post completion of chemotherapy BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2) Exclusion Criteria: History of cranial radiation therapy History of bone marrow transplant History of relapse of ALL Diagnosis of Down's Syndrome Comorbidities of obesity that require immediate subspecialist referral Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity Significant psychiatric or neurologic disorders that would impair compliance with study protocol Current participation in a weight-loss program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia S Kunin-Batson, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16035086
Citation
Rogers PC, Meacham LR, Oeffinger KC, Henry DW, Lange BJ. Obesity in pediatric oncology. Pediatr Blood Cancer. 2005 Dec;45(7):881-91. doi: 10.1002/pbc.20451.
Results Reference
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PubMed Identifier
21495928
Citation
Ness KK, Armenian SH, Kadan-Lottick N, Gurney JG. Adverse effects of treatment in childhood acute lymphoblastic leukemia: general overview and implications for long-term cardiac health. Expert Rev Hematol. 2011 Apr;4(2):185-97. doi: 10.1586/ehm.11.8.
Results Reference
background
PubMed Identifier
19224548
Citation
Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209.
Results Reference
background
PubMed Identifier
21850679
Citation
Cohen J, Wakefield CE, Fleming CA, Gawthorne R, Tapsell LC, Cohn RJ. Dietary intake after treatment in child cancer survivors. Pediatr Blood Cancer. 2012 May;58(5):752-7. doi: 10.1002/pbc.23280. Epub 2011 Aug 17.
Results Reference
background
PubMed Identifier
11044803
Citation
Mayer EI, Reuter M, Dopfer RE, Ranke MB. Energy expenditure, energy intake and prevalence of obesity after therapy for acute lymphoblastic leukemia during childhood. Horm Res. 2000;53(4):193-9. doi: 10.1159/000023566.
Results Reference
background
PubMed Identifier
23816490
Citation
Sherwood NE, Levy RL, Langer SL, Senso MM, Crain AL, Hayes MG, Anderson JD, Seburg EM, Jeffery RW. Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds. Contemp Clin Trials. 2013 Sep;36(1):228-43. doi: 10.1016/j.cct.2013.06.017. Epub 2013 Jun 28.
Results Reference
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Let's Play! Healthy Kids After Cancer

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